240178
IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer
体外诊断检测试剂/试剂盒, 血液学, 纤维蛋白溶解, 纤维蛋白原降解产物, D-二聚体
Siemens Healthcare Diagnostics Products GmbH·C·Hong Kong MDACS·Registered May 21, 2024
Device overview
- Risk class
- C
- Product code
- 19290
- State
- current
- Status
- N/A
- Product code detail
- 19290 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer
Manufacturer (製造商)
- Name
- Siemens Healthcare Diagnostics Products GmbHSiemens Healthineers
- Country
- Germany德国
- Address
- Emil-von-Behring-Str. 76, 35041 Marburg, Germany埃米尔-冯-贝林街76, 35041 马尔堡, 德国
Authorised representative (AR)
- Name
- Sysmex Hong Kong Limited希森美康香港有限公司
- Phone
- 25435123
Regulatory timeline
- Registration date
- May 21, 2024
- Expiry date
- May 20, 2029
Product models
INNOVANCE D-Dimer (OPBP03, OPBP07), INNOVANCE D-Dimer Controls (OPDY03)
INNOVANCE D-二聚体(OPBP03、OPBP07)、INNOVANCE D-二聚体对照品(OPDY03)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer
產品資訊： 体外诊断检测试剂/试剂盒, 血液学, 纤维蛋白溶解, 纤维蛋白原降解产物, D-二聚体